Study of Hepatic Arterial Infusion to Treat Biliary Tract Carcinomas

Phase 2

Completed

• Conditions: Biliary Tract Cancer
• Interventions: Drug: Oxaliplatin, Fluorouracil, Leucovorin, Capecitabine

• Registration Number: NCT01572324
• Lead Sponsor: Peking University

Brief Summary

This Phase II clinical trial is to study the effectiveness and safety of continuous hepatic arterial infusion (HAI) of Oxaliplatin and Fluorouracil in Patients with Unresectable Biliary tract carcinomas, and to explore a better first-line treatment regimen for these patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-04-04
• Study First Submitted QC: 2012-04-04
• Study First Posted: 2012-04-06
• Primary Completion: 2015-10
• Study Completion: 2016-04
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-02
• Last Update Posted: 2017-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Patient must have histologically or cytologically confirmed Biliary tract carcinomas including intrahepatic, hilar cholangiocarcinoma and gallbladder cancer without evident liver metastasis.
• Patient must have locally advanced disease that is unresectable after review by the Hepatobiliary Surgery service
• Patient's Eastern Cooperative Oncology Group (ECOG) performance status must be =< 2 (Karnofsky >= 60%)
• Absolute neutrophil count >= 1,500/mcL
• Platelets >= 100,000/mcL
• Hemoglobin >= 90g/L
• Total bilirubin =< 2 X institutional upper limit of normal
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normality
• Creatinine =< 1.5 X institutional upper limit of normal
• Albumin >= 30g/L
• Patient must be able to understand and willing to sign a written informed consent document

Exclusion Criteria

• Patients who have had prior chemotherapy and other antitumor therapy treatment
• Patient who is receiving any other investigational agents
• Patient who have evident distant (M) disease;
• Patient who have a diagnosis of hepatic encephalopathy
• Patients who have a diagnosis of sclerosing cholangitis.
• Patients who have a diagnosis of Gilbert's disease.
• Patients who have clinical ascites
• Patient must not have any uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes mellitus and hypertension, or psychiatric illness/social situations that would limit compliance with study requirements
• No other malignancy except localized basal cell or squamous cell skin cancer in the past 5 years
• Patient who is pregnant or lactating
• Patient Allergic to Iodine contrast medium
• Uncontrolled severe coagulation disorders (INR < 1.5 in patients not on warfarin therapy)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arterial infusion	Oxaliplatin, Fluorouracil, Leucovorin, Capecitabine	-

Primary Outcome Measures

Name	Time	Method
Response rates	4 months	Describe the overall response rate with a 95% confidence interval.

Secondary Outcome Measures

Name	Time	Method
Toxicity of HAI	1 months	Toxicity as measured by NCI Common Toxicity Criteria
Overall survival	3 years	Describe median overall survival with a 95% confidence interval and estimate the overall survival rate at 12 and 24 months with 24 months with a 95% confidence interval.
Progress free survivial	2 years	Describe median PFS with a 95% confidence interval.

Trial Locations

Locations (1)

Peking University Cancer Hospital; 🇨🇳 Beijing, Beijing, China